JP4982699B2 - Biopsy forceps - Google Patents

Biopsy forceps Download PDF

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JP4982699B2
JP4982699B2 JP2007552238A JP2007552238A JP4982699B2 JP 4982699 B2 JP4982699 B2 JP 4982699B2 JP 2007552238 A JP2007552238 A JP 2007552238A JP 2007552238 A JP2007552238 A JP 2007552238A JP 4982699 B2 JP4982699 B2 JP 4982699B2
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biopsy forceps
sheath
cylindrical member
biopsy
gripping
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JP2008528109A (en
JP2008528109A5 (en
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サーティ，ヴィハー，シー．
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Cook Medical Technologies LLC
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Cook Medical Technologies LLC
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/06—Biopsy forceps, e.g. with cup-shaped jaws
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • A61B2017/2926—Details of heads or jaws
    • A61B2017/2932—Transmission of forces to jaw members
    • A61B2017/2933—Transmission of forces to jaw members camming or guiding means
    • A61B2017/2937—Transmission of forces to jaw members camming or guiding means with flexible part
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • A61B2017/2926—Details of heads or jaws
    • A61B2017/2932—Transmission of forces to jaw members
    • A61B2017/2944—Translation of jaw members

Abstract

A biopsy forceps and method of using the biopsy forceps. The biopsy forceps includes a plurality of grasping members extending from an inner shaft. The plurality of grasping members are biased toward an open configuration. Sliding a sheath over the grasping members constrains the grasping members to a closed configuration. A method of performing a tissue biopsy is also disclosed.

Description

本発明は、生検試料を得るために使用される生検鉗子に関する。 The present invention relates to a biopsy forceps used to obtain a biopsy sample .

本出願は、２００５年１月２０日出願の米国仮特許出願第６０／６４６，１０４号の恩典を請求する。   This application claims the benefit of US Provisional Patent Application No. 60 / 646,104, filed Jan. 20, 2005.

多くの専門分野の医師は、一般に、ガン細胞の様な組織の異常の存在を判定するため、患者から生検試料を入手する。時には、侵襲性の処置を必要とすること無く生検試料が取られることもある。例えば、医師は、黒色腫の試験を行うため、皮膚の生検試料を採取することがある。しかしながら、多くの場合、医師は、患者の腹腔、胸腔、又は胃腸系の内側の生検部位にアクセスしなければならない。その様な処置では、医師は、大きな外傷を伴う切開手術を避けるため、しばしば内視鏡を使用する。最近の内視鏡は、視認システムと、生検鉗子を通すことのできる作業チャネルとを有する長く可撓性を備えた器具である。   Many specialist physicians generally obtain biopsy samples from patients to determine the presence of abnormalities in tissues such as cancer cells. Sometimes biopsy samples are taken without requiring invasive procedures. For example, a doctor may take a skin biopsy sample to test for melanoma. However, in many cases, the physician must access a biopsy site inside the patient's abdominal cavity, thoracic cavity, or gastrointestinal system. In such procedures, physicians often use an endoscope to avoid open surgery with large trauma. Modern endoscopes are long and flexible instruments with a viewing system and a working channel through which biopsy forceps can be passed.

普通の内視鏡生検鉗子は、近位端と遠位端の間を伸張する長いシャフトから形成されている。近位端には、医師が小さな一対の生検ジョー（Ｊａｗ）を制御するのに使用するアクチュエータ機構が設けられている。このジョー（Ｊａｗ）は、生検鉗子の遠位端に位置しており、組織の試料を切断、剪断、又は裂断するための歯が設けられている。内視鏡の作業チャネルを通して使用される生検鉗子では、生検鉗子のジョー（Ｊａｗ）が内視鏡の遠位端から外に伸張して目標の組織に到達できるように、生検鉗子のシャフトは、内視鏡よりも長い。内視鏡を通して生検鉗子を導入する必要のない部位から生検試料を採取する場合は、もっと短い生検鉗子が使用される。   Conventional endoscopic biopsy forceps are formed from a long shaft that extends between the proximal and distal ends. At the proximal end is an actuator mechanism that is used by a physician to control a small pair of biopsy jaws (Jaw). The jaw is located at the distal end of the biopsy forceps and is provided with teeth for cutting, shearing or tearing the tissue sample. For biopsy forceps used through the working channel of the endoscope, the biopsy forceps jaws can be extended out of the distal end of the endoscope to reach the target tissue. The shaft is longer than the endoscope. Shorter biopsy forceps are used when a biopsy sample is taken from a site where it is not necessary to introduce biopsy forceps through an endoscope.

しかしながら、従来の生検鉗子は、数多くの欠点を有している。例えば、アクチュエータとジョー（Ｊａｗ）の機構は、手動組立を必要とする数多くの非常に小さな構成要素で形成されている。生検鉗子の製造には、従って、費用が掛かり、困難で、時間が掛かる。而して、これらの欠点の幾つかでも解決し又は改良する生検鉗子が必要とされている。
米国仮特許出願第６０／６４６，１０４号 However, conventional biopsy forceps have a number of drawbacks. For example, the actuator and jaw mechanism is formed of many very small components that require manual assembly. The manufacture of biopsy forceps is therefore expensive, difficult and time consuming. Thus, there is a need for a biopsy forceps that overcomes or ameliorates some of these drawbacks.
US Provisional Patent Application No. 60 / 646,104

従って、本発明の目的は、上記欠点の内の１つ又はそれ以上を解決又は改善する特徴を有する生検鉗子を提供することである。 Accordingly, it is an object of the present invention to provide a biopsy forceps having features that solve or ameliorate one or more of the above disadvantages.

本発明の或る態様によれば、上記目的は、遠位端及び近位端を有するシースと、遠位端及び近位端を有し、長手軸線を画定する円筒状部材であって、前記細長いシース内に該シースに対して相対的に滑動可能に配置され、当該円筒状部材の前記遠位端から近位端方向に延びるように形成された少なくとも３つの切り込みと、該切り込みの間に画定された少なくとも３つの把持部分と、当該円筒状部材の前記切り込みが設けられていない、該把持部分よりも近位側にある円筒状のシャフト部分とを有し、前記把持部分の少なくとも１つは、その遠位端部を当該円筒状部材の半径方向内側に折り曲げられて形成された切断縁部を有するようになされた円筒状部材とを有し、前記把持部分は、前記シースの遠位端より遠位方向に延びたときに前記半径方向の外向きに湾曲するように付勢されており、前記把持部分は、前記シース内に引き入れられたときは、前記複数の把持部分が前記長手軸線に平行に沿って延びて全体として円筒状となるようにされている、生検鉗子
を提供することによって達成される。前記切断縁部には、刃部分を設けることができる。 According to one aspect of the present invention, the object is a sheath having a distal end and a proximal end, and a cylindrical member having a distal end and a proximal end and defining a longitudinal axis, At least three incisions disposed within the elongate sheath so as to be slidable relative to the sheath and extending from the distal end of the cylindrical member toward the proximal end, and between the incisions Having at least three defined gripping portions and a cylindrical shaft portion proximal to the gripping portion not provided with the notch of the cylindrical member, and at least one of the gripping portions And a cylindrical member adapted to have a cutting edge formed by bending its distal end radially inward of the cylindrical member, wherein the gripping portion is distal to the sheath. The half when extended distally from the end The gripping portion is urged to curve outward in the direction, and when the gripping portion is pulled into the sheath, the plurality of gripping portions extend along the longitudinal axis so as to be generally cylindrical. The biopsy forceps that are supposed to be
Is achieved by providing The cutting edge may be provided with a blade portion .

前記円筒状部材はステンレス鋼で形成することができる。The cylindrical member can be formed of stainless steel.

前記切断縁部の刃部分は、生検部位から組織を裂断する様に構成された鋸歯状の縁部を備えることができる。 The cutting edge blade portion may comprise a serrated edge configured to tear tissue from a biopsy site .

前記シースは円筒形の断面を有するようにすることができる。 The sheath may have a cylindrical cross section .

前記円筒状部材は、組織を電気外科的に切るために電気焼灼源に接続可能とすることができる。 The cylindrical member can be connectable to an electrocautery source for electrosurgically cutting tissue .

前記切断縁部は、前記把持部分が前記シース内に引き入れられたときに、前記円筒状部材の長手軸線に対して直角になるように折り曲げられたものとすることができる。 The cutting edge portion may be bent so as to be perpendicular to the longitudinal axis of the cylindrical member when the grip portion is drawn into the sheath .

前記把持部の少なくとも２つが前記切断縁部を有し、該少なくとも２つの切断縁部は、前記把持部分が前記シース内に引き入れられたときに、前記長手軸線方向で見て、相互に重なるようにすることができる。At least two of the gripping portions have the cutting edge, and the at least two cutting edges overlap each other when viewed in the longitudinal axis direction when the gripping portion is drawn into the sheath. Can be.

以下、本発明の各種実施形態を、添付図面（縮尺は合っていない）を参照しながら例として説明する。   Hereinafter, various embodiments of the present invention will be described by way of example with reference to the accompanying drawings (not to scale).

以下、図面を参照しながら本発明を説明するが、各図を通して、同様の要素には同様の番号を付している。本発明の各種要素の関係と機能は、以下の詳細な説明により、良く理解頂けるであろう。しかしながら、以下に説明する本発明の各実施形態は例に過ぎず、本発明は、図に示す実施形態に限定されるものではない。また、各図面は縮尺が合っているわけではなく、事例によっては、製作及び組み立てに関する従来通りの細部の様な、本発明を理解するのに必要のない詳細事項は省かれているものと理解されたい。更に、ここに説明する本発明は、多種多様な適用先を有する方法論を含んでいることを指摘しておく。   Hereinafter, the present invention will be described with reference to the drawings. In the drawings, similar elements are denoted by the same reference numerals. The relationship and function of the various elements of the present invention will be better understood from the following detailed description. However, each embodiment of the present invention described below is only an example, and the present invention is not limited to the embodiment shown in the drawings. Also, the drawings are not to scale, and in some cases it is understood that details not necessary for an understanding of the present invention, such as conventional details on fabrication and assembly, are omitted. I want to be. Furthermore, it should be pointed out that the present invention described herein includes methodologies having a wide variety of applications.

さて図面を参照してゆくが、図１−３は、本発明の代表的な実施形態を示している。概括すれば、生検鉗子１０は、医療分析用の組織試料を採取するために提供されている。図１に示すように、生検鉗子１０は、遠位端１２を有するカテーテル１１を含んでいる。遠位端１２は、シャフト部分１６と、シャフト部分１６の遠位端１７から伸張する把持部分２６を含んでいる。長手方向軸Ａは、図１と図２に示すように、シャフト部分１６を通って画定されている。把持部分２６は、開いた形態では、長手方向軸Ａに対して外向きに付勢されている。遠位端１２は、更に、内部に管腔１９が画定されている外部シース１８を含んでいる。概括的には、シャフト部分１６は、シース１８の中に（即ち、管腔１９の中に）滑動可能に収容されている。シャフト部分１６はシース１８に対して滑動可能なので、把持部分２６を少なくとも部分的にはシース１８の中へと後退させて、把持部分２６を閉じさせることができる。従来型のハンドル４０（図２に示す）は、カテーテル１１の近位端３６に作動的に接続されている。ハンドル４０は、シャフト部分１６のシース１８に対する動きを制御して、把持部分２６が、外向きに付勢されている開いた形態と、閉じた形態との間の動きを制御するのに使用される。 Referring now to the drawings, FIGS. 1-3 illustrate an exemplary embodiment of the present invention. In general, a biopsy forceps 10 is provided for collecting tissue samples for medical analysis. As shown in FIG. 1, the biopsy forceps 10 includes a catheter 11 having a distal end 12. The distal end 12 includes a shaft portion 16 and a gripping portion 26 extending from the distal end 17 of the shaft portion 16. The longitudinal axis A is defined through the shaft portion 16 as shown in FIGS. The gripping portion 26 is biased outwardly with respect to the longitudinal axis A in the open configuration. The distal end 12 further includes an outer sheath 18 having a lumen 19 defined therein. In general, the shaft portion 16 is slidably received within the sheath 18 (ie, within the lumen 19). Since the shaft portion 16 is slidable relative to the sheath 18, the gripping portion 26 can be retracted at least partially into the sheath 18 to close the gripping portion 26. A conventional handle 40 (shown in FIG. 2) is operatively connected to the proximal end 36 of the catheter 11. The handle 40 is used to control the movement of the shaft portion 16 relative to the sheath 18 to control the movement between the open and closed configurations in which the gripping portion 26 is biased outward. The

図１に示すように、カテーテル１１の遠位端１２は、シャフト部分１６と、把持部分２６と、シース１８を含んでいる。或る実施形態では、３本の把持部分２６がシャフト部分１６から伸張しているが、当業者には理解頂けるように、把持部分２６の数は、２、３、４、５本、又はそれ以上でもよい。把持部分２６は、シャフト部分１６の遠位部分１７に接続されている近位部分２７と、遠位方向に伸張している遠位部分２８と、を含んでいる。把持部分２６は、遠位部分２８が長手方向軸Ａから遠ざかる方向に付勢されている開いた形態では曲線状の輪郭を有し（図１）、閉じた形態では直線状の輪郭を有する（図５）ように図示されている。把持部分は、曲がった輪郭などを含め、別の輪郭であってもよい。或る実施形態では、把持部分２６は、シャフト部分１６の遠位部分１７から伸張し、シャフト部分１６と一体の構造によって、後で述べるチューブの様な単一の細長い部材から形成されることができる。或る実施形態では、把持部分２６とシャフト部分１６が異なる構成要素で作られ、一体に接続されている。例えば、把持部分２６の近位部分２７が別体で形成され、シャフト部分１６の遠位部分１７でシャフト部分１６に接続され、長手方向軸Ａから外向きに或る角度で伸張している。この実施形態では、把持部分２６は、直線状の輪郭、曲線状の輪郭、曲がった輪郭などを有していてもよい。把持部分２６は、図２で見ることのできる外面３１を含んでいる。 As shown in FIG. 1, the distal end 12 of the catheter 11 includes a shaft portion 16, a gripping portion 26, and a sheath 18. In some embodiments, three gripping portions 26 extend from the shaft portion 16, but as will be appreciated by those skilled in the art, the number of gripping portions 26 is two, three, four, five, or more. That's all. The gripping portion 26 includes a proximal portion 27 that is connected to the distal portion 17 of the shaft portion 16 and a distal portion 28 that extends in the distal direction. The gripping portion 26 has a curvilinear profile in the open configuration (FIG. 1) in which the distal portion 28 is biased away from the longitudinal axis A (FIG. 1) and a linear profile in the closed configuration ( FIG. 5). The grip portion may be another contour including a curved contour. In some embodiments, the gripping portion 26, extends from the distal portion 17 of the shaft portion 16, the structure integral with the shaft portion 16, to be formed from a single elongated member such as a tube to be described later it can. In some embodiments, the gripping portion 26 and the shaft portion 16 are made of different components and connected together. For example, the proximal portion 27 of the grip portion 26 is formed separately and is connected to the shaft portion 16 at the distal portion 17 of the shaft portion 16 and extends outward from the longitudinal axis A at an angle. In this embodiment, the gripping portion 26 may have a linear outline, a curved outline, a curved outline, or the like. The gripping portion 26 includes an outer surface 31 that can be seen in FIG.

把持部分２６の内の１つ又はそれ以上には、切断縁部３２が設けられている。或る実施形態では、切断縁部３２は、図２に示すように、把持部分２６に対して内向きに、長手方向軸Ａに向けて曲げられている。切断縁部３２は、把持部分２６に対して９０°に曲げられている。切断縁部３２は、組織を剪断、把持、裂断、又は切断できるように作られている。縁部３２は、切断面を有する刃部分３３を更に有していてもよい。縁部３２と刃部分３３は、限定するわけではないが、単一のブレード又は切断面、鋸歯状、直線状、角張った形、又は曲線状を含め、どの様な形状と構成に形成してもよい。切断縁部３２、刃３３、又は両者は、閉じた形態では縁部３２又は刃３３が遠位部分２８で互いに噛み合うように、互いに嵌り合う形状になっている。図３Ａ−Ｃは、３つの把持部分を有する実施形態を示している。図３Ａは、開いた形態の断面図を示している。図３Ｂは、閉じた形態で重なり合っている長方形の部分を有する切断縁部３２の端面図を示している。図３Ｃは、閉じた形態で重なり合っている三角形の切断縁部３２を有する、別の形状をした遠位部分２８を示している。図３Ｂと３Ｃに示している実施形態も、切断縁部３２に刃３３を含んでいてもよい。別の形状の切断縁部３２を備えた２つの把持部分を有する別の実施形態の端面図を、図８Ａ−８Ｃに示している。 One or more of the gripping portions 26 is provided with a cutting edge 32. In some embodiments, the cutting edge 32 is bent inwardly with respect to the gripping portion 26 and toward the longitudinal axis A, as shown in FIG. The cutting edge 32 is bent at 90 ° with respect to the gripping portion 26. The cutting edge 32 is made so that tissue can be sheared, grasped, torn or cut. The edge portion 32 may further include a blade portion 33 having a cut surface. The edge 32 and blade portion 33 may be formed in any shape and configuration including, but not limited to, a single blade or cutting surface, serrated, straight, angular, or curved. Also good. The cutting edge 32, the blade 33, or both are shaped to fit each other so that the edge 32 or the blade 33 engages with each other at the distal portion 28 in the closed configuration. 3A-C show an embodiment having three gripping portions . FIG. 3A shows a cross-sectional view of the open configuration. FIG. 3B shows an end view of the cutting edge 32 having rectangular portions that overlap in a closed configuration. FIG. 3C shows another shaped distal portion 28 having triangular cutting edges 32 that overlap in a closed configuration. The embodiment shown in FIGS. 3B and 3C may also include a blade 33 at the cutting edge 32. End views of another embodiment having two gripping portions with different shaped cutting edges 32 are shown in FIGS. 8A-8C.

切断縁部３２は、例えば、切断縁部３２が把持部分２６の遠位部分２８の一部を長手方向軸Ａに向けて曲げることによって形成されているときは、縁部３２が互いに嵌り合う適切な寸法形状となるように、切断縁部３２から材料を取り除くことによって形成されてもよい。刃３３を有する実施形態では、刃３３は、切断縁部３２に互いに同様に嵌り合うような寸法形状に作られる。代わりに、切断縁部３２、刃３３、又は両者は、把持部分２６の遠位部分２８に、所望の寸法形状となるよう材料を付け加えることによって形成してもよい。 The cutting edges 32, for example, when the cutting edges 32 are formed by bending a portion of the distal portion 28 of the grip portion 26 toward the longitudinal axis A, the edges 32 fit together. It may be formed by removing material from the cutting edge 32 so as to have an appropriate size and shape. In embodiments having blades 33, the blades 33 are sized and shaped to fit into the cutting edge 32 in a similar manner. Alternatively, the cutting edge 32, the blade 33, or both may be formed by adding material to the distal portion 28 of the gripping portion 26 to the desired dimensional shape.

或る実施形態では、切断縁部３２は、図５と図７に示すように、互いに重なり合う寸法形状に作られている。例えば、生検鉗子１０が４つの把持部分２６を含んでいる図７に示すように、互いに反対の対を成す切断縁部３２は、一組の対がもう一組の対より更に遠位方向に伸張して両方の対が重なり合うように互いに噛み合っている。或る実施形態では、各切断縁部３２又は刃３３は、閉じた形態では重なり合って、例えば、生検鉗子１０に３つの把持部分２６が含まれている場合、切断縁部３２は、三角形に作られ、互いに重なり合って、図３Ｂの閉じた形態の端面図に示す、概ね三角形の容器の端部を形成する。閉じた形態において、把持部分２６と縁部３２が閉じた形態で噛み合い又は重なり合うことによって形成されるチャンバの中に試料が保持されるように、縁部３２と刃３３を形成するのに、どの様な寸法形状を用いてもよい。縁部３２は、鈍くてもよいし、組織の試料を患者から採取するための刃３３を含んでいてもよい。 In some embodiments, the cutting edges 32 are sized to overlap each other as shown in FIGS. For example, as shown in FIG. 7 in which the biopsy forceps 10 includes four gripping portions 26, the opposite pair of cutting edges 32 are arranged such that one pair is more distal than the other pair. So that both pairs overlap each other. In certain embodiments, each cutting edge 32 or blade 33 overlaps in a closed configuration, for example, if the biopsy forceps 10 includes three gripping portions 26, the cutting edge 32 is triangular. Made and overlapping each other to form the end of a generally triangular container, shown in the closed end view of FIG. 3B. In the closed configuration, which edge 32 and blade 33 are formed so that the sample is held in a chamber formed by the gripping portion 26 and the edge 32 engaging or overlapping in the closed configuration? Various dimensional shapes may be used. The edge 32 may be blunt or may include a blade 33 for taking a tissue sample from a patient.

或る実施形態では、把持部分２６は、長手方向軸Ａの周りに曲線状になっていて、シャフト部分１６が円筒形の断面である場合には、シャフト部分１６と同様な概ね環状の輪郭を形成している。シャフト部分１６とシース１８は、多角形、長円形などを含め、別の形状の断面形状を有していてもよい。或る実施形態では、切断縁部３２が、図２に示すように長方形になって、把持部分２６の遠位部分２８は平坦になっていていてもよい。或る実施形態では、把持部分２６は、比較的幅広である。把持部分２６は、閉じた形態で把持部分２６が互いにカム運動をしたときに把持部分２６によって形成されるチャンバ又は容器の中に組織の試料を捕捉するために使用される。把持部分２６の長手方向の縁部２９は、隣接する把持部分の長手方向の縁部２９が噛み合い又は近接して、生検鉗子１０が閉じた形態にあるときに組織の試料を保持するためのチャンバを形成するような寸法形状に作られている。閉じた形態の例は、図５に示されている。上記形態は、縁部３２が、生検対象の組織をしっかりと把持して切断又が裂断できるようにし、組織の試料が生検鉗子１０から抜け出るのを防いでいる。 In some embodiments, the gripping portion 26, they become curved about the longitudinal axis A, in the case Yafuto portion 16 is cylindrical in cross-section, generally annular contour similar to the shaft portion 16 Is forming. The shaft portion 16 and the sheath 18 may have a different cross-sectional shape including a polygon, an oval, and the like. In some embodiments, the cutting edge 32 may be rectangular as shown in FIG. 2, and the distal portion 28 of the gripping portion 26 may be flat. In some embodiments, the gripping portion 26 is relatively wide. Grip portion 26 is used to grip portion 26 in a form closed to capture a sample of tissue in the chamber or vessel is formed by the grip portion 26 when the camming together. The longitudinal edges 29 of the gripping portions 26 are for holding tissue samples when the biopsy forceps 10 are in a closed configuration with the longitudinal edges 29 of adjacent gripping portions engaged or in close proximity. It is sized and shaped to form a chamber. An example of the closed configuration is shown in FIG. The above configuration allows the edge 32 to securely grasp and cut or tear the tissue to be biopsied and prevent the tissue sample from slipping out of the biopsy forceps 10.

或る実施形態では、把持部分２６とシャフト部分１６は、当業者には既知の弾性材料で作られている。曲げ応力に耐え、事前に成形された形状に弾性的に戻ることができるのであれば、どの様な弾性材料でも使用することができる。或る実施形態では、生検鉗子１０又はその構成要素を形成するのに金属が使用されている。代表的な金属には、ステンレス鋼、又はニチノール（NiTi）の様な超弾性特性を有する合金が含まれる。シャフト部分１６と把持部分２６は、ステンレス鋼管の単一の部品から形成することもできる。従来型のプログラム可能レーザーカッターをプログラムして、管材を所望の形状にレーザー切断してもよい。レーザーカッターは、所望の形状を単一の長い管材から繰り返して切り出すようにプログラムすることもできる。レーザーカッターは、同様に、管材を切り込んで任意の数の把持部分２６（例えば、３、４、５、６又はそれ以上の把持部分）を形成するようにプログラムすることもできる。代わりに、把持部分２６は、シャフト部分１６に溶接してもよいし、当業者には既知の何らかの技法を使ってシャフト部分１６に取り付けてもよい。各把持部分２６は、寸法形状が同じでもよいし、或いは、寸法形状が異なっていて、例えば、幅広と幅狭の把持部分２６、又は長い及び短い対の把持部分２６が交互していてもよい。レーザーカッターを使って、切断縁部３２とは３３を、任意の所望の寸法形状に、例えば縁部３２の材料の一部を取り除くことによって、形成してもよい。 In some embodiments, the gripping portion 26 and shaft portion 16 are made of an elastic material known to those skilled in the art. Any elastic material can be used as long as it can withstand bending stress and elastically return to a pre-shaped shape. In some embodiments, metal is used to form biopsy forceps 10 or a component thereof. Typical metals include stainless steel or alloys with superelastic properties such as Nitinol (NiTi). The shaft portion 16 and the gripping portion 26 can also be formed from a single piece of stainless steel pipe. A conventional programmable laser cutter may be programmed to laser cut the tubing into the desired shape. The laser cutter can also be programmed to repeatedly cut the desired shape from a single long tube. The laser cutter can also be programmed to cut the tubing to form any number of gripping portions 26 (eg, 3, 4, 5, 6 or more gripping portions ). Alternatively, the gripping portion 26 may be welded to the shaft portion 16 may be attached to the shaft portion 16 by using some of the known techniques to those skilled in the art. Each gripping portion 26 may have the same dimensional shape, or may have different dimensional shapes, for example, wide and narrow gripping portions 26, or a pair of long and short gripping portions 26 may alternate. . Using a laser cutter, the cutting edge 32 and 33 may be formed to any desired size and shape, for example by removing a portion of the material of the edge 32.

図１−３に示すように、シース１８は、把持部分２６を拘束するため、シャフト部分１６の一部を覆って滑動可能に配置することができる。シース１８をシャフト部分１６に対して滑動させ、把持部分２６の外面３１の少なくとも一部と係合させると、把持部分２６を閉じた形態に拘束することができる。或る代表的な実施形態では、シース１８は、シャフト部分１６に対して約２ｍｍから１０ｍｍの間の距離だけ滑動させることができるが、当業者であれば、シース１８がシャフト部分１６に対して滑動する距離を変えることができる。シャフト部分１６をシース１８の中へと後退又は滑動させると、或いは代わりに、シース１８にシャフト部分１６の上を前進滑動させると、シース１８は、把持部分２６を閉じた形態へとカム運動させて、把持部分２６を拘束する。或る実施形態では、シャフト部分１６、シース１８、又はその両者は、把持部分２６の外面３１を含め、互いに接触する面上にポリテトラフルオロエチレン（ＰＴＦＥ）の様な潤滑材の薄層を有する部分を含んでいる。シース１８をシャフト部分１６に対して滑動させると、把持部分２６と縁部３２は、生検対象の組織をしっかりと把持して、切断、剪断、又は裂断する。シース１８が把持部分２６の少なくとも一部を覆って滑動可能に配置されている閉じた形態では、細い形状にもなっており、内視鏡の作業チャネルの様な生検鉗子を通して容易に送り込むことができる。装置１０の全体寸法形状は、装置１０が使用されることになる場所によって変わる。 As shown in FIGS. 1-3, the sheath 18 can be slidably disposed over a portion of the shaft portion 16 to constrain the grip portion 26. The sheath 18 is slid relative to the shaft portion 16, when engaged with at least a portion of the outer surface 31 of the gripping portion 26 can be constrained to the closed configuration the grip portion 26. In certain exemplary embodiments, the sheath 18 can be slid relative to the shaft portion 16 by a distance of between about 2 mm and 10 mm, although those skilled in the art will recognize that the sheath 18 is relative to the shaft portion 16. The sliding distance can be changed. When the shaft portion 16 is retracted or slid into the sheath 18, or alternatively, the sheath 18 is advanced and slid over the shaft portion 16, the sheath 18 cams the gripping portion 26 into a closed configuration. Thus, the grip portion 26 is restrained. In some embodiments, shaft portion 16, sheath 18, or both have a thin layer of lubricant, such as polytetrafluoroethylene (PTFE), on surfaces that contact each other, including outer surface 31 of gripping portion 26. Contains parts. As the sheath 18 is slid relative to the shaft portion 16, the grasping portion 26 and the edge 32 firmly grasp the tissue to be biopsied and cut, shear, or tear it. The closed configuration, in which the sheath 18 is slidably disposed over at least a portion of the grasping portion 26, is also thin and can be easily fed through a biopsy forceps, such as a working channel of an endoscope. Can do. The overall size and shape of the device 10 will vary depending on where the device 10 is to be used.

生検鉗子装置１０の操作は、当業者には既知のどの様な方法で実行してもよい。例えば、生検鉗子装置１０の遠隔操作は、近位端３６でハンドル４０を介して制御される（図２に拡大された遠位部分１２を示している）。当業者には明らかになるように、多種多様なハンドル機構を、本発明では使用することができる。ハンドル４０は、サムリングでも、鋏型のハンドルでも、ピンバイスでも、或いは、シースを制御ワイヤ又はシャフト部分に対して動かすのに適していれば、どの様な他の従来型のハンドルでもよい。ハンドル４０は、シャフト部分１６又はシース１８に接続されている制御ワイヤに接続されていてもよい。概括的には、ハンドル４０を使って制御ワイヤを作動させ、制御ワイヤが、シャフト部分１６又はシース１８の内の一方の他方に対する動きを制御する。加えて、ハンドル４０は、生検鉗子装置１０を操縦するのにも使用される。 The operation of the biopsy forceps device 10 may be performed by any method known to those skilled in the art. For example, remote operation of the biopsy forceps device 10 is controlled via the handle 40 at the proximal end 36 (shown with the enlarged distal portion 12 in FIG. 2). A wide variety of handle mechanisms can be used in the present invention, as will be apparent to those skilled in the art. The handle 40 may be a thumb ring, a saddle type handle, a pin vise, or any other conventional handle suitable for moving the sheath relative to the control wire or shaft portion . The handle 40 may be connected to a control wire that is connected to the shaft portion 16 or the sheath 18. In general, the handle 40 is used to actuate a control wire that controls movement relative to one of the shaft portion 16 or the sheath 18. In addition, the handle 40 is also used to steer the biopsy forceps device 10.

装置１０のシャフト部分１６と把持部分２６にエネルギーを供給するため、電気的コネクタが設けられている。電気的コネクタは、雄型プラグを形成し、電気コード（アクティブコードと呼ばれることもある）に繋ぐようになっているのが便利である。電気コードは、例えば Valleylab Inc.(ボールダー、コロラド州) 製の標準的な電気外科発電機に接続することができる。使用時、医師は、発電機を介して、装置１０に電流を流すか否かを制御し、通常は、足踏みペダルを使って制御ワイヤに電気を流し、ステム、把持部分、又は切断縁部に接触する組織を切除する。これによって、医師は、シャフト部分１６、把持部分２６、又は切断縁部３２で組織を切断し又は出血している組織を焼灼することができる。シース１８は、或る実施形態では、当業者には理解頂けるように、プラスチック又はゴムの様な絶縁材で被覆されている。 An electrical connector is provided to supply energy to the shaft portion 16 and the gripping portion 26 of the device 10. The electrical connector conveniently forms a male plug and is adapted to connect to an electrical cord (sometimes called an active cord). The electrical cord can be connected to a standard electrosurgical generator, for example, manufactured by Valleylab Inc. (Boulder, CO). In use, the physician controls whether the device 10 is energized through a generator, and usually uses a foot pedal to power the control wire to the stem, grasping portion , or cutting edge. Excise the tissue that makes contact. This allows the physician to ablate tissue that is cutting or bleeding at the shaft portion 16, the gripping portion 26, or the cutting edge 32. The sheath 18 is coated in some embodiments with an insulating material such as plastic or rubber, as will be appreciated by those skilled in the art.

本発明の実施形態の中には、生検鉗子装置１０が注入液供給源又は吸引源に作動的に接続されているものもある。例えば、或る実施形態では、真空又はシリンジのような吸引源が、組織の剥離、又は生検部位周辺の一般的流体の除去を支援するためシャフト部分１６に接続されている。真空源は、生検試料をシャフト部分１６の中に引き込んで剥離させるため、又は複数の生検試料を採取するためにも使用される。代わりに、又は追加して、生検鉗子装置１０をシリンジ又はポンプのような注入液供給源に作動的に接続し、シャフト部分１６を通して流体を生検部位に送り込むこともできる。例えば、食塩水、染料、又は薬物を、シャフト部分１６を通して生検部位に注入することもできる。生検装置１０には、必要に応じて注入又は吸引を行うため、シャフト部分１６に加えて別の管腔を設けてもよい。当業者には既知のどの様な注入装置又は吸引源でも、生検装置１０に作動的に接続することができる。 In some embodiments of the present invention, the biopsy forceps device 10 is operatively connected to an infusate supply source or a suction source. For example, in some embodiments, a vacuum or a suction source, such as a syringe, is connected to the shaft portion 16 to assist in tissue detachment or removal of common fluid around the biopsy site. The vacuum source is also used to draw the biopsy sample into the shaft portion 16 for separation, or to collect multiple biopsy samples. Alternatively or additionally, the biopsy forceps device 10 can be operatively connected to an infusate source such as a syringe or pump to deliver fluid through the shaft portion 16 to the biopsy site. For example, saline, dye, or drug can be injected through the shaft portion 16 into the biopsy site. The biopsy device 10 may be provided with another lumen in addition to the shaft portion 16 for infusion or aspiration as required. Any infusion device or suction source known to those skilled in the art can be operatively connected to the biopsy device 10.

図４は、本発明を利用して目標の組織から生検試料を切り取る１つの方法を示している。ステップ８０に示すように、目標の組織の位置を、例えば内視鏡を使って突き止める。目標の組織を突き止めたら、生検鉗子装置１０を、例えば、ステップ８４に示すように内視鏡の作業チャネルを通して生検鉗子装置１０を導入することによって、目標の組織まで送り込む。代わりに、装置１０は、組織を突き止める際に同時に組織に送り込んでもよい。目標の組織を突き止めたら、ステップ８８に示すように、装置１０を目標の生検組織に向けて、切断縁部３２及び／又は把持部分２６が目標の生検組織に接触するまで前進させてもよい。手順のこの時点で、ステップ９２に示すように、医師は、ハンドルを操作してシャフト部分１６又はシース１８の何れかを滑動させ、把持部分２６を所定の位置まで操縦し、次いで把持部分２６を少なくとも部分的にはシース１８の中へとカム運動させ、把持部分２６を閉じた形態へ動かして、目標の生検組織を把持する。その後、ステップ９６に示すように、医師は、把持部分２６とシャフト部分１６にエネルギー供給源でエネルギーを供給するか、又は単に、装置１０を組織から引き離すことによって、生検試料を裂断し、剪断し、又は切り離す。随意的に、ステップ９８に示すように、医師は、ステップ８８−９６を繰り返すことによって目標組織の試料を追加して採取してもよい。所望の数の生検試料を採取したら、ステップ１００に示すように、医師は、装置１０を引き出して、分析用の生検試料を回収することができる。 FIG. 4 illustrates one method of cutting a biopsy sample from target tissue using the present invention. As shown in step 80, the position of the target tissue is located using, for example, an endoscope. Once the target tissue is located, the biopsy forceps device 10 is fed to the target tissue, for example, by introducing the biopsy forceps device 10 through the working channel of the endoscope as shown in step 84. Alternatively, the device 10 may be delivered to the tissue at the same time as locating the tissue. Once the target tissue is located, the device 10 may be advanced toward the target biopsy tissue until the cutting edge 32 and / or the gripping portion 26 contact the target biopsy tissue, as shown in step 88. Good. At this point in the procedure, as shown in step 92, the physician operates the handle is slid to either of the shaft portion 16 or sheath 18, to steer the grip portion 26 to a predetermined position, and then the grip portion 26 At least partially camped into the sheath 18 and the grasping portion 26 is moved to a closed configuration to grasp the target biopsy tissue. Thereafter, as shown in step 96, the physician ruptures the biopsy sample by supplying energy to the grasping portion 26 and shaft portion 16 with an energy source or simply pulling the device 10 away from the tissue, Shear or cut off. Optionally, as shown in step 98, the physician may take additional samples of target tissue by repeating steps 88-96. Once the desired number of biopsy samples have been collected, as shown in step 100, the physician can withdraw the device 10 and collect the biopsy sample for analysis.

本発明の開示した実施形態の様々な要素の構造又は構成のこの他の開示していない又は付随的な詳細事項は、どの様なものであれ、その要素が、開示しているように機能するのに必要な属性を有している限りにおいて、本発明の利点を実現するのに重要であるとは考えられない。これら及びその他の構造の詳細事項の選択は、本発明の開示に鑑み、例え初歩的な者であっても当業者であればその能力の範囲内にあると考えられる。以上、本発明の例証的な実施形態について、実際的な作動的構造を開示して本発明を好都合に実施できるようにすることを目指して、相当詳細に説明してきた。ここに説明した設計は、代表例を示したに過ぎない。本発明の新規な特徴は、本発明の精神及び範囲から逸脱すること無く、他の構造的形態に組み込むこともできる。特に指定しない限り、ここで用いている全ての普通の単語及び用語は、その慣習的意味が The New Shorter Oxford English Dictionary, 1993年版 に準拠しているものとする。全ての技術的用語は、その慣習的意味が、該当する分野の当業者が普通に活用している適切な技術的規律によって確立されたものに則っているものとする。全ての医療用語は、その意味が、Stedman’s Medical Dictionary, 第27版に則っているものとする。   Any other undisclosed or attendant details of the structure or configuration of the various elements of the disclosed embodiments of the invention function as disclosed. As long as it has the necessary attributes, it is not considered important to realize the advantages of the present invention. Selection of these and other structural details is considered within the scope of the abilities of those of ordinary skill in the art, even in the light of the present disclosure. The exemplary embodiments of the present invention have been described in considerable detail with the aim of disclosing practical operating structures to facilitate the practice of the present invention. The design described here is only a representative example. The novel features of the invention can also be incorporated in other structural forms without departing from the spirit and scope of the invention. Unless otherwise specified, all common words and terms used herein shall conform to the customary meaning of The New Shorter Oxford English Dictionary, 1993 edition. All technical terms shall have their customary meanings established by appropriate technical discipline commonly used by those skilled in the relevant field. All medical terms have their meanings in accordance with Stedman ’s Medical Dictionary, 27th edition.

本発明の或る実施形態による生検鉗子頭部の斜視側面図である。1 is a perspective side view of a biopsy forceps head according to an embodiment of the present invention. FIG. 生検鉗子頭部とハンドルの側面図である。It is a side view of a biopsy forceps head and a handle. 図３Ａは、本発明の或る実施形態による生検鉗子頭部の断面図であり、図２の３−３線に沿う開いた形態を示している。FIG. 3A is a cross-sectional view of a biopsy forceps head according to an embodiment of the present invention, showing an open configuration along line 3-3 of FIG. 図３Ｂは、長方形の縁部を有する図３Ａに示す実施形態の閉じた形態の端面図である。FIG. 3B is an end view of the closed configuration of the embodiment shown in FIG. 3A having a rectangular edge. 図３Ｃは、三角形の縁部を有する図３Ａに示す実施形態の別の実施形態の閉じた形態の端面図である。FIG. 3C is an end view of the closed configuration of another embodiment of the embodiment shown in FIG. 3A with triangular edges. 本発明の或る実施形態による生検鉗子を使用する方法のフローチャートである。2 is a flowchart of a method of using biopsy forceps according to an embodiment of the present invention. 本発明の或る実施形態による生検鉗子の側面図である。1 is a side view of a biopsy forceps according to an embodiment of the present invention. FIG. 本発明の或る実施形態による生検鉗子頭部の断面正面図である。1 is a cross-sectional front view of a biopsy forceps head according to an embodiment of the present invention. FIG. 本発明の或る実施形態による生検鉗子頭部の端面図である。1 is an end view of a biopsy forceps head according to an embodiment of the present invention. FIG. 図８Ａは、長方形の縁部を備えた２つの把持部分を有する或る実施形態の閉じた形態を示す端面図である。FIG. 8A is an end view showing a closed configuration of an embodiment having two gripping portions with rectangular edges. 図８Ｂは、曲線状の縁部を備えた２つの把持部分を有する或る実施形態の閉じた形態を示す端面図である。FIG. 8B is an end view showing a closed configuration of an embodiment having two gripping portions with curved edges. 図８Ｃは、三角形の縁部を備えた２つの把持部分を有する或る実施形態の閉じた形態を示す端面図である。FIG. 8C is an end view showing a closed configuration of an embodiment having two gripping portions with triangular edges.

Claims (9)

生検鉗子において、
遠位端及び近位端を有する細長いシースと、
遠位端及び近位端を有し、長手軸線を画定する円筒状部材であって、前記細長いシース内に該シースに対して相対的に滑動可能に配置され、当該円筒状部材の前記遠位端から近位端方向に延びるように形成された少なくとも３つの切り込みと、該切り込みの間に画定された少なくとも３つの把持部分と、当該円筒状部材の前記切り込みが設けられていない、該把持部分よりも近位側にある円筒状のシャフト部分とを有し、前記把持部分の少なくとも１つは、その遠位端部を当該円筒状部材の半径方向内側に折り曲げられて形成された切断縁部を有するようになされた円筒状部材と、を備えており、
前記把持部分は、前記シースの遠位端より遠位方向に延びたときに前記半径方向の外向きに湾曲するように付勢されており、
前記把持部分は、前記シース内に引き入れられたときは、前記複数の把持部分が前記長手軸線に平行に沿って延びて全体として円筒状となるようにされている、生検鉗子。In biopsy forceps,
An elongate sheath having a distal end and a proximal end ;
A cylindrical member having a distal end and a proximal end and defining a longitudinal axis, wherein the cylindrical member is slidably disposed within the elongate sheath relative to the sheath, the distal end of the cylindrical member At least three incisions formed to extend proximally from the end, at least three grasping portions defined between the incisions, and the grasping portion not provided with the incisions of the cylindrical member And a cutting edge formed by bending at least one of the gripping portions radially inward of the cylindrical member. And a cylindrical member configured to have
The gripping portion is biased to curve outward in the radial direction when extending distally from a distal end of the sheath ;
The biopsy forceps , wherein when the grasping portion is drawn into the sheath, the plurality of grasping portions extend in parallel with the longitudinal axis so as to be cylindrical as a whole . 前記切断縁部が、刃部分を備えている、請求項１に記載の生検鉗子。It said cutting edge, and a blade portion, biopsy forceps according to claim 1. 前記円筒状部材はステンレス鋼で形成する、請求項１又は２に記載の生検鉗子。The biopsy forceps according to claim 1 or 2 , wherein the cylindrical member is made of stainless steel. 前記切断縁部は、生検部位から組織を裂断する様に構成された鋸歯状の縁部を備えている、請求項１乃至３のいずれかに記載の生検鉗子。The biopsy forceps according to any one of claims 1 to 3, wherein the cutting edge includes a serrated edge configured to tear tissue from a biopsy site. 前記シースは円筒形の断面を有している、請求項１乃至４のいずれかに記載の生検鉗子。The biopsy forceps according to any one of claims 1 to 4 , wherein the sheath has a cylindrical cross section. 前記円筒状部材は、組織を電気外科的に切るために電気焼灼源に接続可能である、請求項１乃至５のいずれかに記載の生検鉗子。The biopsy forceps according to any of the preceding claims, wherein the cylindrical member is connectable to an electrocautery source for electrosurgically cutting tissue. 前記切断縁部は、前記把持部分が前記シース内に引き入れられたときに、前記円筒状部材の長手軸線に対して直角になるように折り曲げられている請求項１乃至６の何れかに記載の生検鉗子。The cutting edge is bent so as to be perpendicular to the longitudinal axis of the cylindrical member when the grip portion is drawn into the sheath. Biopsy forceps. 前記把持部分の少なくとも２つが前記切断縁部を有し、該切断縁部は、前記把持部分が前記シース内に引き入れられたときに、前記長手軸線方向で見て、相互に重なるようにされている請求項１乃至７の何れかに記載の生検鉗子。 At least two of the gripping portions have the cutting edge, the cutting edges being overlapped with each other when viewed in the longitudinal axis direction when the gripping portion is drawn into the sheath. The biopsy forceps according to any one of claims 1 to 7 . 前記把持部分は、前記シース内に部分的に引き入れられたときに、前記複数の把持部分が前記長手軸線に平行に沿って延びて全体として円筒状となるようにされている請求項１乃至８の何れかに記載の生検鉗子。9. The gripping portion is configured such that when the pulling portion is partially drawn into the sheath, the plurality of gripping portions extend in parallel with the longitudinal axis so as to be cylindrical as a whole. The biopsy forceps according to any one of the above.
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AU2006206544A1 (en) 2006-07-27
EP1838229B1 (en) 2009-08-26
DE602006008740D1 (en) 2009-10-08
ATE440552T1 (en) 2009-09-15
JP2008528109A (en) 2008-07-31
WO2006078743A1 (en) 2006-07-27
CA2595379A1 (en) 2006-07-27
CA2595379C (en) 2011-10-11
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US20060178699A1 (en) 2006-08-10
AU2006206544B2 (en) 2010-08-26

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